Guidant Issues Second Defibrillator Warning

The medical device maker says five additional models may need to be recalled. Also, Boston Scientific settles a stent probe.

A second safety warning from Guidant Corp., one of the nation's largest medical device manufacturers, urged doctors to stop using five defibrillator models because they could malfunction and may have to be recalled.

Indianapolis-based Guidant announced its second worldwide safety advisory in a week Friday, after voluntarily recalling seven defibrillator models last week.

The pager-sized, implantable devices sense an irregular heart rhythm and shock the heart back into correct beating. At least 74,900 defibrillators are now under a company warning.

At Emory University in Atlanta, Dr. Jonathan Langberg was preparing to replace a defibrillator of a patient whose model was recalled by Guidant last week. But the model set to be implanted Friday morning received a safety warning, too.

Langberg, director of cardiac electrophysiology at the university, said his patient instead received a defibrillator from Medtronic Inc., Guidant's main competitor.

"The patients I've seen in the clinic are understandably worried about whether their safety net has got holes in it," he said. The latest Guidant safety announcement affects the Contak Renewal 3 model, the company's largest seller, and Contak Renewal 4, as well as the Renewal RF. It also covers the Renewal 3 and the Renewal 4 AVT models.

The five models have a magnetic switch that can become stuck in a closed position, preventing the device from treating irregular heart rhythms. The faulty switch also can limit a defibrillator's battery life.

In cases where one of the five defibrillator models has been implanted, Guidant said physicians should reprogram the device so its magnet use is off. The devices will continue to function. Patients who hear beeping tones from the defibrillators, however, should go to the emergency room immediately.

"Guidant is in the very early stages of diligent evaluation of the component failure," company spokesman Steve Tragash said Friday. "We are implementing a conservative step of halting implants until we are satisfied with device performance."

Also Friday, Boston Scientific Corp. agreed to pay $74 million to settle an investigation of the medical device maker's 1998 recall of nearly 35,000 coronary stents that the government alleged continued to be sold for nearly two months despite defects in the device used to implant them.

Boston Scientific admitted no wrongdoing in the settlement of a civil complaint that followed a criminal probe that stretched for more than six years.

The defect did not involve the stents, but the device used to implant them, called a catheter.

The company took a $75-million charge against its third-quarter earnings last year in expectation of the settlement. Boston Scientific's shares fell 30 cents, or 1.1%, to $27.51.